Recruiting

MicroEFfAECTAntimicrobial Therapy for Enterococcus Faecalis Bacteremia and Gut Microbiota Signature

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What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2021
See protocol details

Summary

Principal SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Study ContactMaddalena Giannella, MD PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 6, 2021

Actual date on which the first participant was enrolled.

This study is focusing on Enterococcus faecalis, a type of bacteria that normally lives in the human gut but can sometimes cause serious infections, including bloodstream infections. These infections are becoming more common, especially in older populations, and they can lead to high mortality rates. Traditional treatment often involves using a single antibiotic, ampicillin, but newer studies suggest that combining different antibiotics might work better in severe cases. The study aims to explore how combinations of antibiotics, like ceftaroline and ceftobiprole with ampicillin or daptomycin, could improve patient outcomes. Additionally, researchers are interested in how these treatments affect the balance of bacteria in the gut, which can be disturbed by antibiotics and lead to further health issues. Participants in the study will receive either a single antibiotic or a combination of antibiotics to treat their infection. Researchers will then track the effectiveness of these treatments by looking at clinical outcomes such as cure rates and any side effects. The study will also use laboratory tests to see how well the antibiotic combinations work together, comparing these results with patient outcomes. By doing this, the study hopes to find the most effective treatment strategy and understand how it affects gut bacteria, potentially leading to better ways to manage these infections and reduce the spread of antibiotic-resistant bacteria.

Official TitleEfficacy of Optimized Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia and Identification of Intestinal Microbiota Signature
NCT06833593
Principal SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Study ContactMaddalena Giannella, MD PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

510 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Adult (≥18 years) * Monomicrobial EF-BSI * Receipt of ≥ 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin), at common suggested dosages for EF-BSI in empirical or definitive therapy * Written informed consent Exclusion Criteria: * Short term (within 3 days from BSI) mortality * Other concomitant infection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Ospedale Maggiore "Carlo Alberto Pizzardi" di Bologna

Bologna, ItalyOpen Ospedale Maggiore "Carlo Alberto Pizzardi" di Bologna in Google Maps
Recruiting

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy
Recruiting

Azienda Ospedaliero Universitaria di Catanzaro "Mater Domini"

Catanzaro, Italy
Recruiting

Humanitas Research Hospital

Milan, Italy
Recruiting
4 Study Centers
MicroEFfAECT | Antimicrobial Therapy for Enterococcus Faecalis Bacteremia and Gut Microbiota Signature | PatLynk